Attention should be paid to drug packaging contain

2022-06-21
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Big subject of small packaging: drug packaging containers should pay attention to the fact that the drug administration law of the people's Republic of China clearly regulates the management of drug packaging. Packaging materials and containers that directly contact drugs must meet the pharmaceutical requirements and the standards to ensure human health and safety, The drug supervision and administration department shall examine and approve the drugs at the same time. Drug manufacturers shall not use unapproved packaging materials and containers that directly contact the drugs. The "good manufacturing practice for drugs" also puts forward clear requirements for drug packaging materials. Therefore, while implementing GMP, pharmaceutical enterprises should not ignore the management of drug packaging materials. First, they should check the purchase of packaging materials, and then do a good job in inspection, warehousing Delivery and other specific tools in a word, the management of packaging materials is an important part of GMP. Only by doing a good job in every step can we control the quality of packaging materials and effectively ensure the smooth implementation of GMP

drugs play an important role in maintaining public health, and their quality has been closely concerned by the government. As active chemicals play a role in drugs, their stability is directly affected by packaging materials and packaging forms, so the packaging of drugs should be paid special attention

in order to effectively ensure the quality of drugs, relevant departments must take corresponding measures to improve the quality of drug packaging, establish and improve the standards and management specifications for drug packaging, especially pharmaceutical plastic materials, as soon as possible, and eliminate the hidden dangers of unsafe drug use caused by improper packaging

in recent years, medical plastic bottle packaging has developed rapidly in China. The medical plastic bottle has the advantages of light weight, no damage and sanitation, and meets the special requirements of drug packaging. The application of high-quality medical plastics is inseparable from the improvement of special technical requirements including environment, equipment and personnel

characteristics of plastic packaging containers

pharmaceutical packaging materials belong to the category of special packaging, which not only has all the attributes of packaging, but also has particularity

the materials of plastics include PE, CPP, BOPE, BOPET, BOPA, etc. Due to its strong comprehensive advantages and incomparable advantages of other materials, it will cause certain harm to the environment, but it is still popular. The consumption has increased rapidly and has partially replaced other materials such as glass bottles. Drug manufacturers can select appropriate pharmaceutical packaging according to the barrier performance requirements of drugs on packaging materials and the packaging form of drugs, and comprehensively consider other factors such as transparency, aesthetics, convenience of taking drugs, economy, etc. Plastic packaging containers are packaging materials that directly contact drugs. Therefore, in order to ensure that drug packaging materials can be used to wrap drugs, it is necessary to monitor the quality of these materials. According to the specificity of the use of drug packaging materials, they have the following characteristics:

a. they can protect drugs from the impact of the environment during storage and use, and maintain the original properties of drugs

b. the nature of the drug during storage and use 1. Safety protection: it should have a certain stability

c. drug packaging materials shall not pollute the drug production environment when wrapping drugs

d. drug packaging materials shall not contain substances that may affect the drug during use

e. the drug packaging materials shall not have chemical and biological reactions with the packaged drugs. Requirements for packaging raw materials

packaging materials, especially those in direct contact with drugs, play a decisive role in ensuring the stability of drugs, so the applicability of materials will directly affect the safety of drugs. Unsuitable materials can cause the migration, adsorption, adsorption, or even chemical reaction of active drug components, resulting in drug failure, and sometimes serious toxic and side effects. Therefore, before selecting container materials for drugs, it is necessary to verify whether they are suitable for the intended use, fully evaluate the impact on the stability of drugs, and evaluate their protective effects on drugs under different environmental conditions during long-term storage

according to relevant national laws, regulations and standards, mainly confirm the characteristics of materials, and set special inspection items according to different materials, such as vinyl chloride monomer for PVC and acetaldehyde residue for PTA. Secondly, the chemical and physical properties of the materials are tested, mainly including the amount of the material leached in various solvents, harmful substances, residual solvents in the composite materials, container tightness, etc. Finally, the microbial quantity and safety of the material shall be checked. If the instrument is not applicable, the dust cover shall be used to cover it to prevent dust invasion

during the production of pharmaceutical plastic bottles, it is inevitable to produce recycled materials. In order to reduce costs, individual manufacturers will use recycled materials in excess or in full. After repeated use, the physical properties of the returned material will change, which will lead to the embrittlement and strength reduction of the product, affect the storage life of the drug, and even reduce its internal quality

requirements for packaging production environment

pharmaceutical plastic bottle manufacturers must have a clean production environment, and the ground, road and transportation of the plant should not pollute the production of products. The overall layout of production, administration, living and auxiliary areas shall be reasonable and shall not interfere with each other. The plant shall be reasonably arranged according to the production process flow and the required air cleanliness level. Production operations in the same plant and between adjacent plants shall not interfere with each other. In the design and construction of the plant, it shall be considered that it is easy to clean when it is used. For drug packaging materials, the cleanliness requirements of each process after the product is formed shall be the same as the production cleanliness of the packaged drugs

the design, type selection and installation of the equipment shall meet the production requirements, be easy to clean, disinfect or sterilize, be convenient for production operation, repair and maintenance, and prevent errors and reduce pollution. The surface of the equipment in direct contact with the drug packaging materials that are in direct contact with the drug packaging materials that are used without washing shall be smooth, easy to clean or disinfect, corrosion-resistant, and free from chemical changes with the drug packaging materials. The lubricant and coolant used in the equipment shall not pollute the drug packaging materials. The production equipment shall have obvious status signs, and shall be regularly repaired, maintained and verified. The operation of equipment installation, repair and maintenance shall not affect the product quality. Unqualified equipment shall be moved out of the production area if possible, and there shall be obvious signs before moving out

requirements for the quality of packaging containers

the technical personnel of the survival enterprise of pharmaceutical plastic bottles should understand the chemical and physical properties of the packaging of their pharmaceutical bottles, and should be clear about whether the raw materials and auxiliary materials selected for bottle making have an impact on the packaged drugs. If the dosage of the plastic bottle is not appropriate, the migration of its trace components will change the medicinal effect of the drug, and even endanger the life safety of the drug users. Drugs are a kind of special commodities. Manufacturers producing pharmaceutical plastic bottles should strictly control each production link, comply with the relevant requirements of "GMP", and master the relevant laws and regulations as well as the standards and requirements for pharmaceutical plastic bottles. At present, most of the pharmaceutical plastic bottles in China are used for the packaging of tablets and capsules. Therefore, the produced plastic bottles must protect the drugs from moisture deterioration, heat dissolution, cracking, discoloration, decomposition, oxidation and bacterial contamination

packaging materials and containers in direct contact with drugs are an integral part of drugs, which accompany the whole process of drug production, circulation and use. Due to different drug packaging materials, container composition, selected raw and auxiliary materials and production processes, some components may be dissolved by the drugs they come into contact with, or interact with the drugs, or be corroded by the drugs for a long time, which will directly affect the drug quality. Moreover, some have hidden dangers to the drug quality and human body, such as ampoules and infusion bottles. If different formulations and production processes are not adopted for different drugs, the components will often be dissolved and the glass flakes will fall off, which can not be found in the routine drug inspection. For example, the foreign protein dissolved in the natural rubber plug may be a heat source for the human body, the dissolved pyridine compounds are a positive factor for carcinogenesis and teratogenesis, and the subtle glass flakes are a hidden danger of blockage of blood vessels, thrombosis or pulmonary granuloma. On the other hand, due to the variety of drugs and the complexity of effective active groups, the requirements for packaging materials and containers in direct contact with them are much higher than those for other products

Author: yaojiawen

reprinted from: China's packaging industry

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